Kornimate/medical-research-clean huggingface dataset:
caregivers of children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Caregiver Burden; Exercise; Physical Activity

Summary: this study aims to examine the relationship between caregiving burden and physical activity, exercise self-efficacy, and perceived exercise benefits and barriers in caregivers of caregivers of children with autism spectrum disorder (cwasd).the study population consisted of primary caregivers of a cwasd for at least 1 year. caregiving burden was assessed using the zarit caregiver burden scale, physical activity using the international physical activity questionnaire-short form (ipaq-sf), exercise self-efficacy using the exercise self-efficacy scale, and perceived exercise benefit using the exercise benefits/barriers scale. the relationship between caregiver burden and other parameters was analysed.


Eligibility criteria:
inclusion criteria: * over 18 years of age, * caring for a cwasd for at least 1 year, * the child with autism is 18 years old or younger, * being an informal carer, * the caregiver is the person with primary responsibility for the care of the cwasd in the family. exclusion criteria: * people over the age of 65, * those without a diagnosed chronic physical condition leading to disability, * those caring for more than one cwasd, another disabled person, an older adult or someone needing care
management of miller class i & ii gingival recession

Conditions: Gingival Recession

Summary: management of miller class i \& ii gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft null hypothesis: in patients with miller class i and ii gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * systemically healthy patients. * miller's class i and ii recession defects with recession depth ≥ 2mm. * presence of identifiable cemento-enamel junction (cej). * clinical indication and/or patient request for recession coverage. * smoking ≤ 10 cigarettes/day. * cooperative patients able and accept to come for follow up appointments. exclusion criteria: * pregnant females. * smoking ˃ 10 cigarettes/day. * contraindication for periodontal surgery. * patients with poor oral hygiene. * recession defects associated with caries or restoration as well as * teeth with evidence of a pulpal pathology * molar teeth
scintigraphic assessment of i- transport in metastatic breast cancer and evaluation of i31i ablative therapy: (part i) radioiodide imaging study

Conditions: Breast Cancer

Summary: the purpose of this study is to examine breast cancers that express the protein (nis) that may be found in malignant breast tissues and to evaluate proteins found in blood and their relationship to nis, to test whether iodide can be concentrated by breast cells to possibly treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive iodine entering breast cancer cells, how long your cancer retains the agent as well as how much is taken up by other organs, particularly the thyroid gland.

to demonstrate iodide uptake capacity of breast cancer metastases by imaging women with iodide radioisotope (123i) and calculating potential ablative dose of radioactive iodide (131i).

Eligibility criteria:
inclusion criteria:- only women diagnosed with breast cancer * 18 years of age or older * from whom informed consent can be obtained * patient is able to provide a fluid (e.g. cyst fluid) * patient with blood test that shows protein may allow iodide to accumulate in breast tissue * patient who's breast cancer cells accumulated i123 and held on to it for 24 hours exclusion criteria:- males * children
long-term lead chelation therapy and progressive renal insufficiency

Conditions: Urologic Disease

Summary: previous study showed repeated lead chelation therapy significant reduced progressive renal insufficiency in patients with chronic renal diseases and high-normal body lead burden in a placebo-controlled, randomized, 2-year clinical trial, even factors that influence progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary protein excretion were well controlled.since relative small sample size and short duration of follow-up were noted in the previous study, whether repeated lead chelation therapy could long-term retard the progression of renal insufficiency remains unknown. hence, we conducted a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated chelation in progressive renal insufficiency of patients with high-normal body lead burden.


Eligibility criteria:
inclusion criteria: * patients from 18 through 80 years of age who had chronic renal insufficiency were eligible if they had a serum creatinine concentration between 1.5 mg per deciliter (132.6 μmol per liter) and 3.9 mg per deciliter (344.8 μmol per liter), with a decrease in the glomerular filtration rate of less than 5 ml per minute over a period of at least six months * blood pressure less than 140/90 mm hg * a cholesterol level below 240 mg per deciliter * daily protein intake under 1 g per kilogram of body weight * no known history of exposure to lead or other heavy metals, and a high-normal body lead burden (between 60 and 600 μg, as measured by edta mobilization testing and 72-hour urine collection). exclusion criteria: * patients who have renal insufficiency with a potentially reversible cause, such as malignant hypertension, urinary tract infection, hypercalcemia, or drug-induced nephrotoxic effects * systemic diseases, such as connective-tissue diseases or diabetes mellitus * use of drugs that might alter the course of renal disease, such as nonsteroidal anti-inflammatory agents, steroids, or immunosuppressive drugs * rapidly progressive glomerulonephritis or a high level of 24-hour urinary protein excretion (more than 8 g per day) * previous marked exposure to lead and other metals(lead poisoning or occupational exposure) * drug allergies * absence of informed consent.

Keywords: repeated chelation therapy progressive renal insufficiency body lead burden long-term outcome glomerular filtration rate
hemotol: efficacy and safety of hemodialysis on-line monitoring devices on hemodynamic stability in intensive care unit

Conditions: Hemodialysis

Summary: the purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

acute kidney injury (aki) is associated with high mortality and morbidity rates in critically ill patients despite advances in renal replacement therapy (rrt). over the last few years, new devices in dialysis equipment, such as blood temperature and blood volume on-line monitors, have been developed to improve hemodynamic tolerance, and these new modalities have demonstrated their positive impact on decrease in intra-dialytic hypotension rate in chronic hemodialysis patients. in order to evaluate these new devices in critically ill patients with acute kidney injury we decided to conduct a prospective randomized controlled trial. we based calculation of the sample size on a power analysis that assumed an expected decrease in intra-dialytic hypotension rate of 40% (from a crude intra-dialytic hypotension rate of 30% to 18%) in groups b and c, compared with group a. analysis is done by intention to treat, according to prescribed new dialysis on-line monitoring devices.

Eligibility criteria:
inclusion criteria: * age \> 18 years * acute kidney injury requiring intermittent hemodialysis exclusion criteria: * age \< 18 years * end-stage renal failure * inclusion in other protocol * absence of consent

Keywords: acute kidney injury critical care hypotension renal replacement therapy efficacy tolerance outcome
using transcutaneous auricular vagus nerve stimulation to treat acute alcohol withdrawal

Conditions: Alcohol Withdrawal; Alcohol Use Disorder

Summary: the purpose of this study is to see if stimulation of the vagus nerve via a non-invasive device placed behind external ear can reduce physical and psychological discomfort during acute alcohol withdrawal in patients with alcohol use disorder when people just stop drinking alcohol and in detoxification stage.

the management of acute alcohol withdrawal is a clinical challenge, in part because there are limited medications available for the condition and the majority of the medications are controlled substances, which may cause significant adverse effects and can be potentially addictive. the rationale for using transcutaneous auricular vns (tavns) on a specific target area of the ear is based on anatomical studies suggesting that this area is the only place on the human body surface where there is afferent vagus nerve distribution (mercante et al., 2018). therefore, direct stimulation of the afferent nerve fibers on the ear can produce an effect similar to that by implanted device-generated vns yet without the need of surgical intervention. although tavns has not been tested for treatment of aud, it interestingly appears to be very similar to auricular acupuncture that has been widely used for aud. however, acupuncture needs to be administered by medical providers who have undergone long trainings and own special licensure, which is usually unavailable in acute detoxification units where patients receive treatment for acute alcohol withdrawal. the pilot study will enroll 70 evaluable subjects who are in inpatient detoxification unit randomized to receive single-blind treatment with vagus nerve stimulation or sham stimulation (1:1, vns: sham). evaluable subjects are those who complete stimulations (vns) or sham 5 minutes twice a day for 4 days.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years (men and women); 2. primary current diagnosis of dsm-v alcohol use disorder as indicated at admission; 3. being admitted to inpatient detoxification unit; 4. no evidence of significant cognitive impairment with a mini mental state examination (mmse; folstein et al., 1975) score \> 22; 5. able and willing to give written informed consent and comply with the requirements of the study protocol. exclusion criteria: 1. current dsm-v substance use disorders (other than tobacco / cannabis/ alcohol); 2. serious psychiatric illnesses, e.g. psychotic disorders or bipolar disorder 3. severe medical illnesses, present or history of, e.g. hepatic encephalopathy, delirium 4. history of significant medical problems associated with drinking including seizures; 5. pregnancy; 6. severe intellectual/cognitive deficits due to korsakoff's syndrome, dementia, head injury, or others 7. treatment with an anti-cholinergic medication, including over the counter medications, 8. implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.

Keywords: vagus nerve stimulation (vns), non-invasive intervention
(gastrografin use in small bowel obstruction caused by adherences)

Conditions: Adhesive Small Intestine Obstruction

Summary: adhesive small intestine obstruction (asio) is an important cause of hospital admission and a very common disease. any improvement in this field will benefit many patients by reducing the operative rate. patients with this disease are difficult to evaluate and to manage and their treatment is controversial. emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. on the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. the role of water-soluble contrast medium (gastrografin®: gg) in asio is still debated with regard to the therapeutic value. the aim of our study was to determine the therapeutic role of gastrografin in patients with small intestine obstruction without strangulation caused by adherences (asio).


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) * history of previous abdominal surgical procedures * clinical and radiological evidence of adhesive small intestine obstruction without signs of strangulation and peritonism * asa i-iii patients * informed consent exclusion criteria: * suspicion of strangulation * actual presence or high suspicion of intra-abdominal malignancy * suspicion or history of peritoneal carcinomatosis * active inflammatory bowel disease * positive history of radiotherapy on the abdominal region * obstructed hernias

Keywords: gastrointestinal adhesive small intestine obstruction oral water soluble contrast non-operative conservative management operative rate hospital stay
efficacy and safety of alogliptin used combination with metformin in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (qd) combined with metformin taken twice daily (bid) or three times daily (tid) in type 2 diabetic patients with uncontrolled blood glucose.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. the present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

Eligibility criteria:
inclusion criteria: 1. had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (week 0). 2. had an glycosylated hemoglobin (hba1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (week -4). 3. had an hba1c difference between 4 weeks after the initiation of the observation period (week -8) and 8 weeks after the initiation of the observation period (week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (week -8) (\*rounded off to the first decimal place). 4. was receiving specific diet and exercise (if any) therapies during the observation period. exclusion criteria: 1. had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (week 0). 2. with a history or symptoms of lactic acidosis.

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
cardiac biomarkers in patients with single ventricle physiology

Conditions: Hypoplastic Left Heart; Congenital Heart Disease; Cyanotic Congenital Heart Disease; Cardiac Disease

Summary: all neonates with congenital heart disease undergoing stage one palliation (norwood procedure, damus-kaye-stansel procedure) at texas children's hospital will be regularly monitored for b-type natriuretic peptide (bnp) and troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. these cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via sickbay.

all neonates with congenital heart disease undergoing stage one palliation (norwood procedure, damus-kaye-stansel procedure) at texas children's hospital will be regularly monitored for b-type natriuretic peptide (bnp) and troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. these cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via sickbay.

Eligibility criteria:
inclusion criteria: clinical diagnosis of hypoplastic left heart syndrome as congenital heart disease as a neonate exclusion criteria: other diagnosis of congenital heart disease than hypoplastic left heart syndrome patients older than 30 days

Keywords: troponin bnp biomarkers hypoplastic left heart norwood dks
micro array analysis in preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is a frequent pathology. his etiology is doubtful. targets : the study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells. design: multidisciplinary study (gynaecology-obstetric, immunology, north cic). the study of the transcriptional history of peripheral blood cells of 2patients groups: * a patient group with a preeclampsia before 34 sa * a patient group with a normal pregnancy paired on main confusion factors. blood sampling will be collected at the diagnosis and 8 weeks after delivery. results and perspectives * obtain a transcriptionnal signature of preeclampsia * to identify new mechanism of the disease * identification of a specific transcriptom analysis with the comparison after delivery for long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.


Eligibility criteria:
inclusion criteria: * a prééclampsie (blood pressure superior to 140 mmhg and to 90 mmhg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 limited companies and before 34 limited companies. * an informed consent signed by the patient will necessarily have to be obtained. * woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project. * caucasian patient * wait primigeste and nullipare exclusion criteria: * major patient protected by the law. * patient deprived of freedom for administrative or judicial reasons. * patient not benefiting from a national insurance scheme. * refusal of the patient to participate in the study. * not caucasian patient * multipare wait * multiple pregnancy * existence of foetal deformation explaining a delay of growth or a foetal death in utero. * age 18 years and \> 40 years. * absence of written consent or impossibility to receive the written consent (language or understanding).
trans-obturator mid-urethral sling and the single-incision sling in women with stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: mid-urethral slings (mus) now represent a gold standard in the treatment of female stress urinary incontinence (sui). second generation trans-obturator slings (tot) have proven to be as effective as retropubic tension-free vaginal tape (tvt) with fewer major complications. a third generation of the mus inserted through a single vaginal incision (sis) has become a means to overcome significant post-operative groin pain. novel types of sis with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (om). objective of this study was to compare an inside-out tot with an innovative fixation sis in randomized controlled trial on patients undergoing their primary surgery for urodynamic sui.

objective of this study was to compare an inside-out tot (gynecare tvt obturator system, ethicon) with an innovative fixation sis (ophira, promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic sui. a prospective randomized controlled trial (rct) is performed in one tertiary referral urogynecology center from january 2015 thru december 2015. study included women with pure or predominant urodynamic sui confirmed during cystometry by positive standardized cough stress test (cst) with urinary bladder filling of 250 ml in lithotomy position. study was carried out on a caucasian czech (central european) population. a study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. a minimum sample size of 80 patients was required for each group.

Eligibility criteria:
inclusion criteria: women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (cst) with urinary bladder filling of 250 ml in lithotomy position. exclusion criteria: * patients with predominant urge incontinence * patients with intrinsic sphincter deficiency (mucp\<20 cmh2o) * pelvic organ prolapse (pop-q\>2) * previous urinary incontinence surgery * previous pelvic organ prolapse surgery * presence of other pelvic organ pathology.
evaluation of a remote monitoring smartphone application and care model of covid-19 patients in the community (recover)

Conditions: COVID

Summary: this is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with covid-19 infection managed in community isolation. we will recruit 2000 covid +ve patients aged 18 years and over who are managed at home. the objective will be to describe the rates of avoidable presentations to ed and 30 day all case mortality per diagnosed covid-19 case and to compare these to a propensity matched and synthetic control group.


Eligibility criteria:
inclusion criteria: 1. age greater or equal to 18 years 2. able to provide informed consent 3. proven diagnosis of covid-19 based on positive virology testing 4. patients who are being managed at home or those who are being discharged from hospital for ongoing home-based care in isolation. 5. access to a smartphone or device that is compatible with the tcc-covid app * any iphone or ipad running ios 9 or above (essentially any iphone 5 or above) * any android phone that is operating android 7.0 or above 6. speaks adequate english exclusion criteria: 1. patient meets clinical criteria for hospital-based care. 2. inability to use the tcc-covid app and pulse oximeter due to reasons including but not limited to: * cognitive impairment * impaired dexterity * visual impairment * language barrier 3. patient residing outside the seslhd catchment area during their period of isolation